- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555241
Emergence of Generative Language
December 2, 2016 updated by: Alice Shillingsburg, Emory University
Instructional Programming to Promote the Emergence of Generative Language in Children With Autism Spectrum Disorder
The purpose of this study is to investigate the effects of several applied behavior teaching procedures on the use of multi-word utterances by children with autism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Autism Spectrum Disorder (ASD)
- Provide a diagnostic report confirming a diagnosis of ASD and/or obtain a total raw score of 15 or greater on the Social Questionnaire Lifetime Form (SCQ)
- Speaks primarily in one word utterances
- English as their primary language
- Follows simple 1-step instructions
- Transportation/availability to attend 3, 1-hour sessions each week for 12 weeks
Exclusion Criteria:
- Children with significant problem behavior that interferes with structured intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: One Baseline Session
Designated for participants #1 and #2.
Participants complete 1 Baseline Session followed immediately by 12 weeks of standard treatment.
Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks.
Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.
|
The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
|
Experimental: Two Baseline Sessions
Designated for participants #3 and #4.
Participants complete a Baseline Session followed by a 12 week wait period before repeating a Baseline Session followed immediately by 12 weeks of standard treatment.
Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks.
Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.
|
The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
|
Experimental: Three Baseline Sessions
Designated for participants #5 and #6.
Participants complete a Baseline Session followed by two repetitions of the Baseline Session (each 12 weeks apart) and 12 weeks of standard treatment immediately following the third session.
Standard treatment will require the participant to attend clinic-based treatment sessions for 1 hour per day, 3 days per week, for 12 weeks.
Standard treatment will consist of 3 components: mand training, matrix training, and stimulus equivalence training.
|
The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Length of Utterances (MLU) during manding
Time Frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
The mean length of utterances (MLU) during manding will be evaluated in a 10 minute probe.
The goal of intervention is to increase of MLU to an average of 3 words per mand.
|
Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
Acquisition of noun-verb and color-shape combinations during tacting
Time Frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
The goal of intervention is mastery of 80% of evaluated noun-verb and color-shape targets.
|
Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
Emergence of intraverbal responses
Time Frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
The goal of intervention is the mastery of 80% of evaluated intraverbal responses (2 for each target, 18 total).
|
Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Macarthur Bates-Communicative Development Inventory (CDI) Score
Time Frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
The Macarthur Bates-Communicative Development Inventory (CDI) is completed by a parent/caregiver and evaluates current word use .
A higher score indicates the use of more words.
|
Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
Observe overall improvements in pragmatic language within social/play interactions with parents/caregivers, as measured on the Direct Observation of Spoken Language (DOSL).
Time Frame: Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
A goal of the intervention is to observe an increase in spontaneous mands, an increase in spontaneous tacts, as well as an increase in intraverbal responses.
|
Baseline (Up to 24 Weeks), End of Standard Treatment (Up to 36 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alice Shillingsburg, Emory University Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
September 17, 2015
First Submitted That Met QC Criteria
September 17, 2015
First Posted (Estimate)
September 21, 2015
Study Record Updates
Last Update Posted (Estimate)
December 5, 2016
Last Update Submitted That Met QC Criteria
December 2, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00080641
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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